Skyrizi

• Generic Name: risankizumab-rzaa injection
• Brand Name: Skyrizi

Skyrizi (Risankizumab-rzaa Injection) side effects drug center

• Related Drugs
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• Health Resources
  Psoriasis
• Drug Comparison
  Skyrizi vs. Cosentyx Skyrizi vs. Enbrel Skyrizi vs. Otezla Skyrizi vs. Simponi Skyrizi vs. Taltz Stelara vs. Skyrizi

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Skyrizi Side Effects Center

What Is Skyrizi?

Skyrizi (risankizumab-rzaa) is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

What Are Side Effects of Skyrizi?

Common side effects of Skyrizi include:

• upper respiratory infections,
• headache,
• fatigue,
• injection site reactions (bruising, redness, fluid leakage, bleeding, infection, inflammation, irritation, pain, itching, swelling, warmth), and
• tinea infections (such as ringworm, athlete's foot and jock itch)

Dosage for Skyrizi

The dose of Skyrizi is 150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4 and every 12 weeks thereafter.

What Drugs, Substances, or Supplements Interact with Skyrizi?

Skyrizi may interact with "live" vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Skyrizi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Skyrizi; it is unknown how it would affect a fetus. It is unknown if Skyrizi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Skyrizi (risankizumab-rzaa) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Skyrizi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily. Call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, body aches;
• shortness of breath, cough, bloody mucus;
• mouth sores, red or swollen gums;
• stomach pain, diarrhea;
• increased urination, burning when you urinate;
• pale skin, easy bruising, unusual bleeding;
• a fungal skin infection--skin sores different from psoriasis, rash or redness, blisters, itching, burning, cracking or peeling, changes in skin color; or
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

If you develop an infection, you may need to postpone your next injection until the infection clears up.

Common side effects may include:

• headache;
• tiredness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• fungal skin infections; or
• pain, redness, itching, bruising, swelling, warmth, bleeding, burning, or other skin irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Skyrizi (Risankizumab-rzaa Injection)

 

Skyrizi Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of labeling:

• Infections [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.

Data from placebo-and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials.

Table 1: Adverse Drug Reactions Occurring in ≥ 1% of Subjects on SKYRIZI through Week 16

Adverse Drug Reactions	SKYRIZI N = 1306 n (%)	Placebo N = 300 n (%)
Upper respiratory infectionsa	170 (13.0)	29 (9.7)
Headacheb	46 (3.5)	6 (2.0)
Fatiguec	33 (2.5)	3 (1.0)
Injection site reactionsd	19 (1.5)	3 (1.0)
Tinea infectionse	15 (1.1)	1 (0.3)
a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis

Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.

Specific Adverse Drug Reactions

Infections

In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 subject-years) compared to 14.7% of the placebo group (56.5 events per 100 subject-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster. In ULTIMMA-1 and ULTIMMA-2, through Week 52, the rate of infections (73.9 events per 100 subject-years) was similar to the rate observed during the first 16 weeks of treatment.

Safety Through Week 52

Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to study discontinuation included pneumonia.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products, including other risankizumab products, may be misleading.

By Week 52, approximately 24% (263/1079) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. Of the subjects who developed antibodies to risankizumab-rzaa, approximately 57% (14% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% of subjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations and reduced clinical response.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Skyrizi (Risankizumab-rzaa Injection)

&Copy; Skyrizi Patient Information is supplied by Cerner Multum, Inc. and Skyrizi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.